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LABELS

Overview

Labeling materials (e.g., container and box labels, inserts or circulars) are regulated items and 

must be approved by the CVB prior to use. Likewise, stocks of labeling materials are under 

controlled access at the firm and are subject to inventory controls.

Regulations and guidance regarding labeling materials are found in the following documents:

9CFR 101.4 Labeling terminology

9CFR 112 Main regulatory section for packaging 

and labeling

VS Memorandum 800.54 Guidelines for the Preparation and 

Review of Labeling Materials

VS Memorandum 800.98

VS Memorandum 800.110

Advertising and Promotional Materials

Exemption from Label Warning 

Concerning Use of modified live IBR 

vaccine in pregnant cows or calves 

nursing pregnant cows, 9 CFR 112.7(e)

VS Memorandum 800.208 Special Labels for Export

APHIS Final Rule 2008-0008 Labeling and Packaging Rule

APHIS Final Rule 2011-0049 Single Label Claims Rule

Definitions

Label: All written, graphic or printed matter appearing on a final container, any immediate 

carton or box, or any accompanying enclosures (leaflets, inserts, circulars).

Sketch: A preliminary draft of a label OR a label considered unsuitable for approval
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Special Label for Export: Label approvable only under the provisions described in VS 

Memorandum 800.208. Practically speaking, these labels contain variances to USDA 

regulations regarding claims and use and therefore would not be allowable solely under the 

flexibility provided in 9CFR 112.2(e). 

Master Label: Finished carton, container, or enclosure label for the smallest size final 

container, which serves as a Master template applicable to other designated size containers

Subsidiary: A corporation in which the licensed corporation owns in excess of 50% of the 

voting stock. 

Division: A marketing unit established by the licensee

Distributor: One who sells, trades, or markets products he does not produce or import

Flow of Information 

1. Labeling materials must be submitted via the portal by portal enabled firms, but may be 

submitted on paper for non-portal enabled firms. Instructions for processing labels electronically 

may be found under “PEL Guide to Processing Labels Submitted Electronically,” 

____Paper submissions require an accompanying APHIS Form 2015, but 

portal submissions do not. Two paper copies must be submitted, although some firms may 

submit additional copies for their own use. The Program Assistants (PA)s automatically return 

any extra copies of the paper labels to the firm, after retaining 1 copy for the CVB. 

Labels may be submitted as preliminary sketches or in final format. Note: Colored computergenerated images (label proofs) that are identical to, and to the same scale as, the actual label are 

acceptable for consideration as final labels.

2. After log-in, labeling materials are routed to the LIE. Supporting documents, such as a 

previously filed sketch of the label, an Outline of Production, or a foreign regulatory 

authorization, are used to aid in review of the current submission. 

3. The LIE will do a line-wise comparison of the newly submitted label with applicable 

supporting documents. The LIE will also review the label for general style and compliance with 

the Outline and 9 CFR 112. Notations may be made on the PEL copy of the paper label or on an 

electronic version, in which case the LIE mark-up will be uploaded to the ML. He/She will

record his/her initials and the date on the bottom left corner of the paper label mounting sheet.

4. When the LIE has completed his/her review, the label submission is forwarded to the 

Reviewer. The Reviewer does his/her own technical review (taking into account the notations 

made by the LIE) and scientific evaluation of the label. It is the Reviewer’s role to decide what 

is supported by filed data and what may need to be changed. Stepwise instructions for 

processing electronic labels are found in the The instructions 

for “writing” in the following instructions apply only to paper submissions. 
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5. After reviewing, the reviewer determines what type of processing stamp should be applied to 

the label. There are 4 CVB label stamps, which have been assigned numbers for easy internal 

reference: #1 (returned as a sketch; not approved for use), #2 (permanent approval), #3 

(approved for temporary use), and #4 (special label for export). See Appendix I for examples.

5.1 If a final label is acceptable without modification, write “#2” on the mounting sheet to 

indicate that the #2 stamp should be added. This includes labels that meet all USDA 

regulations, whether for domestic or export use. See the section of this chapter named 

“Labels for Export Only” for additional instructions on the proper stamp for labels that meet 

foreign regulatory requirements but contain variances to USDA regulations.

 

5.2 Labels submitted as preliminary sketches are always returned as sketches, as are any 

other labels deemed unsuitable for processing or being returned “unprocessed” at the request 

of the firm. Write “#1” on the mounting sheet. 

5.3 If a final format label requires immediate revision, process it as a sketch (use #1 stamp). 

At reviewer discretion, certain minor revisions may be deferred for a limited period of time, 

in which case temporary use may be granted instead.

5.4 If a final label is acceptable for temporary use, write #3 on the mounting sheet and ensure 

that the reviewer comments specify the expiration date. For consistency, the expiration date 

is expressed as the last day of the desired month.

5.5 If multiple labels are submitted in the same ML, it is acceptable to return some of the 

labels as sketches, and some as approved labels, if necessary. You do not have to sketch all 

the labels back to the firm, if only one of the labels requires revision. An explanation 

regarding the sketches should be provided and returned to the firm.

5.6 Labels acceptable for defined transitory periods (e.g., interim true names containing old 

and new taxonomy) should be assigned a #3 stamp, even though the expiration date may be 

years away. Likewise, assign a #3 stamp to labels that should be updated at the next printing. 

(Have the firm estimate how long they anticipate the initial printing to last.) If such labels 

are assigned #2 stamps, there is no mechanism to flag them for archival at the end of their 

allowable use period, nor is there any mechanism to identify these labels for follow-up if they 

are not replaced in a timely manner. 

5.7 Unless other arrangements are made, when a submitted label replaces or supersedes an 

old one, the old label becomes obsolete and is archived as soon as the new one is approved. 

Often, however, the firm will request permission to use existing inventories of the replaced 

label. The firm will specify on the mounting sheet the CVB-issued identification numbers of 

the labels being replaced. If submitting paper, the firm will use Block 8D of the APHIS 

Form 2015 to request permission to use the remaining inventories of superseded labels. If 

this is permissible without modification, do not make a comment. An authorized CVB 

signature on the processed submission indicates CVB concurrence with the stated request. 

The default period to use superseded labels is one year. Expiration dates are standardized to 
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the last day of the 12th month after the date on the processed label (Date returned). Either the 

new or superseded labeling may be used before, or on the expiration date. If the request is 

denied or is acceptable only with modification, provide an explanation in a reviewer 

comment. These “extended use” labels remain in our active files until the expiration date, 

after which they are automatically archived. 

Firms may designate that a label is “in addition to” a previously filed label. “In addition to” 

should be reserved for cases where there is no intention to retire the related label. If the firm

indicates a submitted label is to be used “in addition to” an existing one (instead of as a 

replacement), but you suspect that the firm simply wants to use existing inventory, contact 

the liaison to confirm and edit the information accordingly. 

5.8 Labels and sketches should never be returned “unprocessed,” unless they are submitted 

improperly (e.g., no APHIS Form 2015). In cases where it may seem intuitively appropriate 

to return a submission unprocessed, always return the submission as a sketch. This ensures 

that we retain a copy of the submission in our labeling files. 

6. The reviewer prepares the text that will be appended as reviewer comments to the submission. 

 

6.1 Prepare the text as a word processing document. Use the template 

6.2 Name the document according to the naming convention described in the Office 

Procedures section of this manual (e.g., Est_ProdCode_YYMMDD_LBL). 

6.3 The document should begin with the standard wording found in Appendix II of this 

section of the Reviewer Manual.

6.4 If there are no comments, write “NC” on the paper mounting sheet next to the reviewer 

initials. This provides positive confirmation to the support staff that they do not need to be 

looking for a comment document. 

7. Upload the reviewer comments document as Outgoing Correspondence to the mail log. If no 

comments, add the “No Return Form Comments” tag to the mail log. Forward the submission to 

the super-reviewer electronically in the mail log, and place the physical (paper) submission, if 

applicable, on the desk of the responsible super-reviewer.

8. After the submission has been approved by the super-reviewer, and the section leader, the PA

will process paper labels:

8.1 If there are exceptions, the “CVB Exceptions Attached” box is checked in Block 16 of 

APHIS Form 2015 and the exceptions will be printed.

8.2 Each label mounting sheet will be stamped with the appropriate stamp. Attachments to 

the mounting sheet (e.g., foreign language translations, foreign government approvals) are 
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not typically stamped but will be stapled to the label. These documents are available in the 

“File Room” on Sharepoint.

8.3 Each different label in the submission will be given a unique number, automatically 

generated by LSRTIS. The number is written in red ink on the designated line on the CVB 

stamp. If a #3 stamp is used, the appropriate expiration date also will be entered.

8.4 If applicable, replaced paper labels will be stamped (see Appendix I) to indicate that 

existing inventories may be used through a certain date. 

8.5 The signature line will be prepared on the paper 2015. The date in Block 17 of the 2015 

should match the date of the stamp on the label mounting sheet.

8.7 The paper submission will be returned to the Reviewer for final signature.

9. When the processed submission is returned to the Reviewer, the Reviewer should:

9.1 Confirm that each paper copy of each label or sketch has been stamped with the proper 

stamp. Ensure that the correct label number has been added; this number should coincide 

with the label number written in Block F of APHIS Form 2015. Ensure that temporary use 

labels bear the correct expiration date.

9.2 Confirm that replaced labels for which the firm has requested extended use are properly 

stamped and dated.

9.3 Confirm that the proper reviewer comments have been attached to the 2015. Ensure the 

Exceptions checkbox has been checked in Block 16.

9.4 When each of the above is confirmed, sign the 2015 in Block 16. Return the submission 

to the PA that did the initial processing.

10. The labels will be further processed and filed as described in Step 9 of “Flow of 

Information” for the Outlines of Production chapter, except that obsolete labels for currently 

licensed products are filed in the Label Correspondence file for the firm and not in individual 

product files. Any extra copies submitted by the firm are returned to the firm. Supporting 

documents associated with foreign approvals and/or language translations are filed with the 

label, not the 2015. (Electronically submitted labels are not printed, so they are not found in the 

paper file room. The ML serves as archival storage.)

Reviewing Labels and Sketches

1. All label claims and recommendations for administration and use must be supported by data 

on file at the CVB. No statement may be false or misleading. Labels must meet labeling 

requirements which have recently been updated. For a summary of the impact of the new 

labeling rules, see Appendix 3. 
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1.1 Label claim: Labels for each product must have a claim that describes the expected 

efficacy of the product. There must be a claim for each antigen in the true name of the 

product. The claim is based on the results of the pivotal efficacy study for the given product 

fraction. Historically, the claim had at least 2 components: degree of protection and disease. 

Single tier labeling is now required for most products (vaccines, bacterins, toxoids, and 

immunomodulators). The syntax for the single claim is codified:

o This product has been shown to be effective for the vaccination of healthy (insert 

name of species) X weeks of age or older against (insert name of agent or 

disease). For more information regarding efficacy and safety data, see 

productdata.aphis.usda.gov.

1.1.1 In the case of agents that cause multiple disease syndromes, the syndrome for 

which efficacy has been proven must be included. Example: “Is effective against 

reproductive disease due to porcine respiratory and reproductive syndrome virus.”

Diseases accepted as Syndromes for purposes of single-tier labeling:

Agent Syndromes

PRRS virus Respiratory vs. reproductive forms

E. coli Enteric disease vs. edema disease

Mycoplasma bovis Respiratory vs. mastitis vs. arthritis

BVD virus Respiratory vs. persistently infected 

calves 

Calicivirus Respiratory vs. systemic hemorrhagic

Campylobacter jejuni Enteric vs. abortion

Chlamydia psittaci Respiratory vs. abortion

Bovine coronavirus Respiratory vs. enteric

Equine rhinopneumonitis Respiratory vs. abortion

Haemophilus somnus Respiratory vs. neurological

Streptococcus suis Arthritis vs. pneumonia vs. meningitis

1.1.4 In the case of agents with multiple types or strains that are not necessarily highly 

cross-protective, the claim must specify the type/strain for which efficacy was 

demonstrated (e.g., effective against of persistently infected calves due to bovine virus 

diarrhea type 1).

1.1.5 Old claim syntax is not acceptable for new products. Ensure that all labels meet 

current standards before recommending a product for licensure.

1.1.6 For legacy labels, single tier wording is required by October 31, 2020.

1.1.7 When working with labels with single tier wording, follow the guidance in 

Reviewer Manual Chapter 4.2.2 which describes business processes associated with 

single tier label claims.
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1.1.8 Send all Labels with single tier wording to the single tier confirmation of wording 

activity for review to ensure consistent review.

1.2. Route(s) of administration, number of doses, dose volume, and time interval between 

doses in the initial vaccination series: This must correspond to the protocol used in the 

pivotal efficacy study.

It is not permissible to state on a domestic-use label that a product may be co-administered or 

mixed with another product, even though there may be data on file to support the statement. 

This claim is considered to recommend the use of an unlicensed combination package. 

1.3 Minimum age at vaccination: All new labels should specify a minimum age at 

vaccination, unless the product is for use only in mature breeding animals, but some

historical labels lack this information. The minimum age should correspond to the age of the 

animals used in the field safety and efficacy studies. In cases where SPF animals with no 

maternal antibody are used in efficacy studies, the label may recommend revaccination at 

frequent intervals until maternal antibody has waned. 

Historically, equine and bovine efficacy studies were often conducted using older animals 

after maternal antibodies have waned. Labels for these products could recommend 

vaccination of younger animals provided that the field safety study was conducted in animals 

of that age. In those cases, the labels recommended revaccination at 6 months of age. We 

are allowing firms to format their single tier labeling as follows if the supporting studies were 

conducted prior to the requirement to use minimum-age animals in the licensing studies:

“This product has been shown to be effective for the vaccination of healthy <insert 

species> against disease X. This product was licensed prior to the requirement to define 

a minimum age for use. For more information regarding efficacy and safety data, see 

productdata.aphis.usda.gov.”

1.4. Revaccination interval (after initial vaccination series): Each label must specify 

recommendations for revaccination beyond the initial vaccination series, as appropriate. 

When supported by data, the label may disclose the proven duration of immunity. This may 

be expressed indirectly as a recommended revaccination interval, or the label may expressly 

state that the duration of immunity is at least X days.

If there are no data to support a particular revaccination interval, the label must state that the 

interval is unknown. 

If firms request being able to maintain a connection to historical recommendations, this is the 

recommended format for a 2nd paragraph under the indications statement:

“Historically this product was labeled with a recommendation for revaccination at 6 months 

if used in animals under 6 months, and for annual revaccination thereafter, but no specific 

revaccination schedule has been determined.”
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1.5. Slaughter withdrawal period: For products intended for food-producing animals (including 

horses), a slaughter withdrawal period (required time elapsed between final vaccination and 

slaughter) of at least 21 days must be specified, per 9CFR 112.2(a)(8). This interval is based on 

data (gross lesions and histopathology) provided by the firm that characterizes the vaccination 

site at various time periods after vaccination. See the reviewer manual chapter on adjuvants, and 

Veterinary Services Memorandum 800.51, for more information.

Withdrawal statements are not required on oral antibody products intended solely for 

neonatal use. Although technically these products are subject to slaughter withdrawal times, 

they are used in such a manner that an acceptable withdrawal period (at least 21 days) would 

elapse before the animal was slaughtered.

1.6 Safety precautions: As the result of minor post-vaccination reactions noted during the 

pre-license field safety study or because of public health concerns, it may be appropriate to 

include a safety statement. Examples: “Transient swelling may be observed at the 

vaccination site” or “Accidental injection in humans may cause severe inflammation and 

necrosis.”

2. Besides the data-driven elements described above, final container labels have several other 

required elements. See 9CFR 112.2(a) and VSM 800.54 for details. Note that for very small 

containers, some of the requirements are exempted. VSM 800.54 lists the minimum 

requirements for very small container labels.

The subtopics below contain additional information not specifically stated in either 9 CFR 112 or 

VSM 800.54:

2.1 Name and address of manufacturer (licensee) if produced in the United States. If 

imported, the name and address of the permittee, as well as the name of the foreign 

manufacturer, must be included. See also 9CFR 112.4. 

2.1.1 Subsidiary names may be used interchangeably with the licensee name.

2.1.2 Division and distributor names must be clearly specified as such, and the licensee 

name also must appear. Specific guidance for distributor labels is found in VS 

Memorandum 800.80.

2.1.3 According to 9 CFR 112.4(b) the relationship of the division or marketing unit to 

the licensee shall appear prominently on the label by use of the term “division of” or 

equivalent. The CVB interprets the d/b/a (doing business as) designation as an equivalent 

method of listing the marketing unit relationship.

2.1.4 The manufacturer’s telephone number must appear on the labels. The contact 

number is necessary to enable the consumer to contact someone who knows about the 

manufacture of the product and the published licensing study data. If the firm can provide 

adequate assurances that the distributor is equipped and willing to handle any question 
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about the product, and not just adverse event reports, then the firm could potentially get 

an exemption to list only the distributor telephone number. If the firm cannot provide 

such assurances, but would still like to list the distributor telephone number, then 2 

telephone numbers may be listed on the labels, one for the manufacturer, and one for the 

distributor. 

2.2 USDA Establishment Number: This number must appear on all labels, even those used 

solely for export, as it is recognized by our international trading partners as evidence that the 

label has been approved by APHIS. Imported product must contain the USDA Permit 

Number. The only exceptions are Special Labels for Export, labels for experimental product,

and labels for unlicensed products exported under FDA-EREA, all of which must not bear 

the license number.

2.3 Serial number. Do not use the word “Lot” in lieu of Serial on domestic labels. In the 

U.S., Lot is used to identify individual components of test kits so that they are not confused 

with the serial number of the overall kit. 

2.4 Permitted expiration date for the serial: The label for this information should be 

“Expiration” or “Exp.” on labels for domestic use. 

2.5 The label must be legible. If the label is electronic, it should display at 100% size unless 

there is a statement to the contrary on the mounting sheet. Review at an equivalent of 100% 

to assess readability. 

2.6 Per VSM 800.54 , certain internationally recognized symbols may be used on diagnostic 

kit labels. The list of currently approved symbols is on the CVB website. Additional 

symbols may be considered with appropriate justification, provided the symbol has not been 

disallowed in previous communication. 

2.7 Bilingual or foreign-language labels are permissible, provided that a direct English 

translation is provided. If the label is intended for domestic use, however, English must be 

one of the languages on it. 

3. Carton labels also have required elements and packaging restrictions, described in 9CFR 

112.2(b) and VSM 800.54.

4. Inserts have content expectations described in VSM 800.54. 

5. Products containing certain antigens are subject to additional requirements. See 9CFR 112.7 

for requirements for the following:

• live Newcastle disease virus

• infectious bronchitis virus
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• Marek’s disease virus

• rabies virus 

• modified live infectious bovine rhinotracheitis virus 

• Clostridium hemolyticum

• Clostridium botulinum Type C 

• Erysipelothrix rhusiopathiae 

• canine adenovirus type 2 

• feline panleukopenia virus 

• autogenous biologics 

• Conditional licenses 

• wart vaccine

• normal serum, antiserum 

• diluents not tested for viricidal activity

Considerations should also be made for other specific antigens, including those that may be used 

in program disease eradication efforts. 

Note that other products may have license restrictions that should be reflected on the label. 

Examples: 

• Products for further manufacture (FFM) 

• Other restrictions that pertain to product use (e.g., diagnostic test kits that are to be used 

with a specific marker vaccine, products that are to be used only upon the approval of 

APHIS).

Submission Format

Each label or circular must be mounted on an appropriately labeled mounting sheet. See 9CFR 

112.5(d)(1) for specific requirements. Electronic labels should be mounted on the CVB label 

template; substitutes are not currently allowed. 

The top of a paper mounting sheet should contain: 

• true name and product code 

• label type (label/master label/sketch; container, carton, or circular)

• package size(s) (doses/ml/cc/units) for which the labels will be used 
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The lower left corner of a paper mounting sheet should contain:

• Explanation of the submission (i.e., what label(s) it replaces or is in addition to, if the 

license application is pending)

The following should appear somewhere on the paper mounting sheet:

• if the label is for Export Only

• For foreign language labels, a statement that the text is a direct translation of 

approved English text (or an explanation for differences can be provided)

Labels for Export Only

Firms often submit labels that are used only for serials exported to foreign countries. Use of 

such labels must be authorized by the CVB if the labels are applied to the product while it is in 

the U.S. See 9CFR 112.8 and VSM 800.208 for additional detail. Such labels also undergo 

review and approval in the receiving country, which may have different labeling requirements, or 

allow different labeling statements, than does APHIS. In such cases, labels that do not meet the 

requirements of the 9CFR may be approved for export purposes either under our regular

processing workflow (i.e., with a #2 or #3 stamp) or as a Special Label for Export (i.e., #4 

stamp). 

The following items are needed to approve an export label containing variances to APHIS 

regulations:

• Copy of foreign regulatory authorization from receiving country is required only for 

special labels for export. Copy of foreign regulatory authorization is not required for 

export only labels that include minor variances from current labeling requirements in 

the United States. Minor variances may include disclosure of preservatives, or 

slaughter withdrawal times. The content and appearance of such documentation 

varies greatly from country to country. It may, or may not, include an actual label 

approved by foreign regulators.

• A direct translation of any foreign text, if applicable

• Statement on the mounting sheet that the label is for EXPORT ONLY

The reviewer must determine whether the variances on an export label are “cosmetic” or pertain 

to claims or product use. Cosmetic changes include formatting or text elements required in 

APHIS regulations but, without which, the label maintains acceptable descriptions of product 

expectations (claims) and proper use. Labels containing only cosmetic differences should be 

processed with a #2 or #3 stamp under the flexibilities provided in 9CFR 112.2(e). Those with 

statements for claims or use that have not been approved by the CVB are approvable only under 

the additional flexibility provided in VS Memorandum 800.208 and must be processed with a #4 

stamp. 
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A list of potential variances is maintained in Chapter 4.2.1 Precedents for International Label 

Non-Compliance. The spreadsheet identifies the stamp under which the variance has previously 

been approved and describes any variance-specific instructions for processing. It is the 

responsibility of the reviewer to process labels consistent with those precedents and to request 

that the spreadsheet be updated when new variances arise. 

Labels processed with a #2 or #3 stamp must include the USDA Establishment Number. If a 

label otherwise eligible for a #2 or #3 stamp is submitted without a USDA Establishment 

Number, contact the firm to discuss adding the Establishment Number. The number is a required 

element for approval unless the firm can provide documentation that the foreign regulatory 

authority does not allow it. (This differs from simply providing a foreign approval of a label that 

does not bear the number, as this does not prove that the regulators would have rejected a label 

that did contain the number.)

Labels processed with a #4 stamp must NOT bear the USDA Establishment Number. These 

labels also are not eligible for Certificates of Licensing and Inspection.

The regulatory authorizations from some countries are for a finite period and/or are subject to 

periodic renewal. If a label is processed with a #4 stamp, the CVB approval of the label should 

terminate when the current foreign regulatory authorization expires. There is a space on the #4 

stamp to insert an expiration date (i.e., “Use permitted until...”). If the foreign authorization 

does not expire and is not subject to renewal, then insert the phrase “further notice” in the date 

blank on the #4 stamp (“Use permitted until further notice.”) If an export label is processed with 

a #2 or #3 stamp, it is not necessary to define a CVB expiration date solely because the foreign 

authorization has an expiration.

Note that not all labels designated by the firm as Export Only will be unacceptable for 

domestically marketed product; it simply may be that this is the only intended use that they have. 

When a label is approved as an export only label, the submission must include clarification 

regarding which countries are applicable. The phrase “for export only to (name of the country)” 

should appear on the mounting sheet, or the submission description, or clarified in the synopsis 

of the reviewer response.

Labels for Permitted (Imported) Product

If a label is approved for a product imported under a Permit for General Sale and Distribution, 

add the following comment to the Exceptions section of the APHIS Form 2015:

This label is to be used only on containers and packaging imported into the United States. 

Use of this label on serials (or portions thereof) not imported into the United States is 

prohibited.

This comment is intended to remind foreign manufacturers that they are not to use labels 

identifying the product as licensed by the USDA on any containers of product that they may 

distribute in countries other than the US. The veterinary permit number implies not only that the 
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product is licensed (permitted) in the US, but also that the individual serial (or portion thereof) 

has undergone serial release by APHIS. Only those containers that have been imported into the 

US may bear this assurance.

Master Label Concept

To reduce the amount of paperwork associated with label submissions, the Master Label concept 

(9CFR 112.5(d)(1)) was adopted. Many products are marketed in various package sizes; the 

labels for each size are often identical except for physical size and the text regarding the number 

of doses and recoverable volume. In those cases, it is permissible for the licensee or permittee to 

submit only the label for the smallest package size. This label becomes the Master Label and 

serves as a template for other larger package sizes, which are specified on the mounting sheet. It 

is not necessary to submit the other related presentations; such labels are approved concurrently 

with the submitted Master Label.

Minor Label Changes

Although most label changes must be approved prior to using the modified labels on licensed 

product, there are certain minor changes (9CFR 112.5(c)(2)) that do not require prior approval, 

provided that they do not render the label false or misleading and do not affect legibility. Labels 

containing minor changes, however, must be submitted within 60 days of label use. Currently 

accepted minor changes include: 

• Change in physical dimensions

• Change in color of label print or background

• Addition or deletion of Trade Mark or Registered symbol

• Correction of typographical errors

• Adding or changing barcodes/label control numbers/contact numbers

• Revising or updating logos

• Changing an Est # after an approved merger/acquisition

• Change distributor

Diluent Labels

There are special requirements, described in 9CFR 112.3, for labels placed on inert (i.e., contains 

no biological agents) diluents that are used to reconstitute lyophilized biological products. The 

following must be included:

• The name (Sterile Diluent)

• True name of biological product with which the diluent is packaged (unless the firm 

has another method of matching the correct diluent to the product)

• Recoverable volume, in cc or ml

• Serial number

• Name and address of licensee or permittee
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Additional requirements, described in 9CFR 112.3(f), apply if the diluent and desiccated portions 

will come into contact while the diluent is in its original container.

Approval of labels before a product is licensed or permitted

Approved labeling materials must NOT be returned to the license or permit applicant before the 

license or permit is issued. Sketches may be returned at any time, according to the procedure 

described above. When a final label suitable for use on licensed product is submitted, add a 

“Hold Pending Licensure” tag to the mail log item and, the label is paper, put it in the 

prelicensing file. The label is processed with a #2 (or #3) stamp at the time the license is 

prepared for signature. The PA who prepares the license will process the label. 

Experimental Use Labels

Labels used on unlicensed product for experimental use have specific requirements that are 

discussed in the chapter, “Experimental Shipment of Biological Product.” Such labels do NOT 

undergo the same approval process as labels for licensed product and are not stamped with any 

of the CVB stamps. 

Packaging

Specific packaging requirements are described in 9CFR 112.6 for the following products: 

• Multiple-dose containers that require a diluent for administration

• Single-dose products that require a diluent for administration 

• Poultry products for mass administration (including, but not limited to, administration 

through the drinking water) 

• Marek’s Disease Vaccine

• Poultry vaccines administered to individual birds via automatic equipment 
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Appendix I. CVB Stamps Used on Paper Labeling Materials

#1 stamp—used for sketches

2 stamp—used for permanently approved labels

#3 Stamp; used to approve labels for temporary use (expiration date is entered at the 

bottom)
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#4 Stamp; used to process Special Labels for Export 

Extended use stamp; used when firms request continued use of current inventories of labels 

that have been replaced
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 3 9CFR 112 Integrated Version Showing Impact of Single Tier and 

Packaging/Labeling Rules (inclusive of technical amendments) 

§ 112.1 General. 

(a) Unless otherwise authorized or directed by the Administrator, each biological product prepared at 

a licensed establishment, or imported, shall be packaged and labeled as prescribed in this part before 

it is removed from the licensed establishment or presented for importation: Provided, That biological 

products to be imported for research and evaluation shall be subject to packaging and labeling 

requirements in § 112.9. Provided further, That, unless otherwise exempted, all preparation, including 

packaging and labeling, of biological products shall only be performed in a licensed establishment 

under an approved Outline of Production.

(b) No person shall apply or affix to or include with, or cause to be applied or affixed to or included

with, any carton or final container of a biological product, any label, stamp, mark or statement that is 
Labels 18 of 34

false or misleading in any particular, is not in compliance with the regulations, or is not approved by 

APHIS.

(c) No person shall alter, mark or remove any approved labeling affixed to or included with any 

biological product prior to selling or otherwise distributing such product. In addition, no person shall 

mark any carton, other container, or final container of a biological product so as to falsify the labeling, 

make it misleading, or cause it to be illegible.

(d) Labels that are stamped, printed or glued directly on cartons, other containers, or final containers 

shall be legible throughout the dating period. Biological products bearing labels, which have been 

altered, mutilated, destroyed, obliterated or removed, shall be withheld from the market. 

§ 112.2 Final container label, carton label, and enclosure. 

(a) Unless otherwise provided, final container labels, carton labels, and enclosures (inserts, circulars, 

or leaflets) shall include the information specified in this section.

New Old

(1) The complete true name of the biological 

product which name shall be identical with that 

shown in the product license under which such 

product is prepared or the permit under which it 

is imported, shall be prominently lettered and 

placed giving equal emphasis to each word 

composing it. Descriptive terms used in the true 

name on the product license or permit shall also 

appear. Abbreviations of the descriptive terms 

may be used on the final container label if 

complete descriptive terms appear on the carton 

label and enclosure. The following exceptions 

are applicable to small final containers, and 

containers of interchangeable reagents included 

in diagnostic test kits: 

(i) For small final containers, an abbreviated 

true name of the biological product, which 

shall be identical with that shown in the 

product license under which the product is 

prepared or the permit under which it is 

imported, may be used: Provided, That the 

complete true name of the product must 

appear on the carton label and enclosures; 

(ii) In addition to the true name of the kit, the 

functional and/or chemical name of the 

reagent must appear on labeling for small 

final containers of reagents included in 

diagnostic kits: Provided, That the true 

name is not required on labeling for small 

final containers of interchangeable 

(noncritical) components of diagnostic kits.

(1) The principal part of the true name of the 

biological product which name shall be identical 

with that shown in the product license under 

which such product is prepared, or the permit 

under which it is imported, shall be prominently 

lettered and placed giving equal emphasis to 

each word composing it. Descriptive terms 

used in the true name on the product license or 

permit shall also appear. Abbreviations of the 

descriptive terms may be used on the final 

container label if complete descriptive terms 

appear on a carton label and enclosures;

(2) For biological product prepared in the United 

States or in a foreign country, the name and 

address of the producer (licensee, or subsidiary) 

or permittee and of the foreign producer, and an 

appropriate consumer contact telephone 

number: Provided, That in the case of a 

biological product exported from the United 

States in labeled final containers, a consumer 

contact telephone number is not required; 

however, small single dose containers marketed 

(2) If the biological product is prepared in the 

United States, the name and address of the 

producer (licensee or subsidiary) or if the 

biological product is prepared in a foreign 

country, the name and address of the permittee 

and of the foreign producer.
Labels 19 of 34 

New Old

in the United States must include contact 

telephone information on carton and enclosures.

(3) The United States Veterinary Biologics 

Establishment License Number (VLN) or the 

United States Veterinary Biological Product 

Permit Number (VPN), and the Product Code 

Number (PCN) assigned by the Department, 

which shall be shown only as ‘‘VLN/PCN’’ and 

‘‘VPN/PCN,’’ respectively, except that:

(i) Only the VLN or VPN is required on 

container labels of interchangeable (noncritical) components of diagnostic kits and 

container labels for individual products 

packaged together for coadministration. 

(ii) The PCN may be used in lieu of the true 

name of the kit on small container labels for 

critical components of diagnostic kits. 

(iii) Container labels for individually licensed 

biological products, when marketed as 

components of combination packages, must 

include a statement referring the consumer 

to the carton or enclosure for the PCN of the 

combination package.

(3) The United States Veterinary Biologics 

Establishment License Number (VLN) or the 

United States Veterinary Biological Product 

Permit Number (VPN), and the Product Code 

Number (PCN) assigned by the Department, 

which shall be shown only as ‘‘VLN/PCN’’ and 

‘‘VPN/PCN,’’ respectively, except that: 

(i) Only the VLN or VPN is required on 

container labels of interchangeable (noncritical) components of diagnostic kits and 

container labels for individual products 

packaged together for coadministration.

(ii) The PCN may be used in lieu of the true 

name of the kit on small container labels for 

critical components of diagnostic kits.

(iii) Container labels for individually licensed 

biological products, when marketed as 

components of combination packages, must 

include a statement referring the consumer 

to the carton or enclosure for the PCN of the 

combination package. 

(3) The license or permit number assigned by 

the Department which shall be shown only in 

one of the following forms respectively: “U.S. 

Veterinary License No. ___,” or “U.S. Vet. 

License No. ___,” or “U.S. Vet Lic. No. ___,” or 

“U.S. Veterinary Permit No. ___,” or “U.S. 

Permit No. ___.”

(4) Storage temperature recommendation for the 

biological product stated as 2 to 8 °C or 35 to 46

°F, or both.

(4) Storage temperature recommendation for 

the biological product stated as not over 45 °F. 

or stated as not over 7 °C. or stated as not over 

45 °F. or 7 °C.
Labels 20 of 34

New Old

(5) Full instructions for the proper use of the 

product, including indications for use, target 

species, minimum age of administration, route of 

administration, vaccination schedule, product 

license restriction(s) that bear on product use,

warnings, cautions, and any other vital 

information for the product’s use; except that in 

the case of limited space on final container 

labels, a statement as to where such information 

is to be found, such as ‘‘See enclosure for

complete directions,’’ ‘‘Full directions on carton,’’ 

or comparable statement.

(5) An indications statement to read, “This 

product has been shown to be effective for the 

vaccination of healthy (insert name of species) 

__ weeks of age or older against __. Provided,

That in the case of very small final container 

labels or carton, a statement as to where such 

information is to be found, such as “See 

enclosure for complete directions,” “Full 

directions on carton,” or comparable statement;

(This was moved to subsection 12.)

6) No changes (6) In the case of a multiple-dose final 

container, a warning to use entire contents 

when first opened: Provided, That a diagnostic 

or a desensitizing antigen packaged in a 

multiple-dose final container is exempt;

(7) The following warning statements, or 

equivalent statements, shall appear on the 

labeling as applicable: 

(i) Products other than diagnostic kits: ‘‘Do 

not mix with other products, except as 

specified on this label.’’

(ii) Injectable products and other products 

containing hazardous components: ‘‘In case 

of human exposure, contact a physician.’’

(iii) Products containing viable organisms: 

‘‘Inactivate unused contents before 

disposal.’’

(7) If the biological product contains viable or 

dangerous organisms or viruses, a warning to 

“Burn this container and all unused contents,” 

except that in the case of a small one-dose 

container, the statement “Burn this container” or 

“Burn this vial” may be used.

(8) No change (8) In the case of a biological product 

recommended for use in domestic animals, the 

edible portion of which may be used for food 

purposes, a withholding statement of not less 

than 21 days to read: “Do not vaccinate within 

(insert number) days before slaughter” or “Do 

not vaccinate food-producing animals within 

(insert number) days before slaughter”: 

Provided, That longer periods shall be stated 

when deemed necessary by the Administrator. 

Very small final container labels are exempted 

from this requirement.
Labels 21 of 34

New Old

(9) Same as old version except for addition of 

subsection (v):

(v) A statement similar to “For more

information regarding efficacy and safety 

data, go to productdata.aphis.usda.gov.

(9) The following information shall appear on 

the final container label and carton label, if any, 

but need not appear on the enclosure:

(i) A permitted expiration date;

(ii) The number of doses where applicable;

(iii) The recoverable quantity of the content 

of each final container stated in cubic 

centimeters (cc.) or milliliters (ml.) or units.

(iv) A serial number by which the product can 

be identified with the manufacturer's records of 

preparation: Provided, That when a liquid 

antigenic fraction is to be used instead of a 

water diluent for one or more desiccated 

antigenic fractions in a combination package, a 

hyphenated serial number composed of a serial 

number for the desiccated fraction and the 

serial number for the liquid fraction shall be 

used on the carton;

(10) In the case of a product that contains a 

preservative that is added during the production 

process and is not reduced to undetectable 

levels in the completed product through the

production process, the statement ‘‘Contains 

[name of preservative] as a preservative’’ or an 

equivalent statement must appear on cartons 

and enclosures, if used. If cartons are not used, 

such information must appear on the final 

container label.

(10) In the case of a product which contains an 

antibiotic added during the production process, 

the statement “Contains ___ as a preservative,” 

or an equivalent statement indicating the 

antibiotic added shall appear on cartons and 

enclosures if used: Provided, That if cartons are 

not used, such information shall appear on the 

final container label;

No change (11) The number of final containers of biological 

product and the number of doses in each final 

container shall be stated on each carton label 

for all cartons containing more than one final 

container of biological product. The number of 

final containers of diluent, if any, and the 

quantity in each shall also be stated on each 

carton label.

(12) An indications statement to read, ‘‘This 

product has been shown to be effective for the 

vaccination of healthy (insert name of species) 

__ weeks of age or older against __.’’ Provided, 

That in the case of very small final container 

labels or carton, a statement as to where such 

information is to be found, such as ‘‘See 

enclosure for complete directions,’’ ‘‘Full 

directions on carton,’’ or comparable statement.

No prior #12. What now is in #12 used to be in 

subsection 5..

(b) Labels may also include any other statement which is not false or misleading and may include 

factual statements regarding variable response of different animals when vaccinated as directed but 

may not include disclaimers of merchantability, fitness for the purpose offered, or responsibility for the 

product.
Labels 22 of 34

(c) Labels of biological products prepared at licensed establishments or imported shall not include 

any statement, design, or device, which overshadows the true name of the product as licensed or 

which is false or misleading in any particular or which may otherwise deceive the purchaser.

New Old

d) Carton labels and enclosures shall be subject 

to paragraph (d)(1), (d)(2), and (d)(3) of this 

section.

(1) The statement, “Restricted to use by or 

under the direction of a veterinarian” or 

“Restricted to use by a veterinarian,” shall 

be used on all carton labels and enclosures 

when such restriction is prescribed on the 

product license.

(2) If the licensee states on the carton 

labels and enclosures of a product that its 

sales are restricted to veterinarians, then 

the entire production of that particular 

product in the licensed establishment shall 

be so restricted by the licensee.

(3) The statement ‘‘For use in animals only’’ 

may appear on the labeling as appropriate 

for a product to indicate that the product is 

recommended specifically for animals and 

not for humans.

(d) Carton labels and enclosures shall be 

subject to paragraph (d)(1), (d)(2), and (d)(3) of 

this section.

(1) The statement, “Restricted to use by or 

under the direction of a veterinarian” or 

“Restricted to use by a veterinarian,” shall 

be used on all carton labels and enclosures 

when such restriction is prescribed on the 

product license.

(2) If the licensee states on the carton 

labels and enclosures of a product that its 

sales are restricted to veterinarians, then 

the entire production of that particular 

product in the licensed establishment shall 

be so restricted by the licensee.

(3) The statement “For veterinary use only” 

or an equivalent statement may appear on 

the carton labels and enclosures for a 

product if such statement is being used to 

indicate that the product is recommended 

specifically for animals, and not for humans

(e) When label requirements of a foreign 

country differ from the requirements as 

prescribed in this part, special labels may be

approved by APHIS for use on biological 

products to be exported to such country upon

receipt of written authorization, acceptable to 

APHIS, from regulatory officials of the importing 

country, provided that:

(1) If the labeling contains claims or 

indications for use not supported by data on 

file with APHIS, the special labels for export 

shall not bear the VLN.

(2) All other labels for export shall bear the 

VLN unless the importing country provides 

documentation that the VLN is specifically 

prohibited. When laws, regulations, or other 

requirements of foreign countries require 

exporters of biological products prepared in 

a licensed establishment to furnish official 

certification that such products have been 

prepared in accordance with the VirusSerum-Toxin Act and regulations issued 

pursuant to the Act, such certification may 

be made by APHIS.

(e) When label requirements of a foreign 

country conflict with the requirements as 

prescribed in this part, special labels may be 

approved for use on biological products to be 

exported to such country. When laws, 

regulations, or other requirements of foreign 

countries require exporters of biological 

products prepared in a licensed establishment 

to furnish official certification that such products 

have been prepared in accordance with the 

Virus-Serum-Toxin Act and regulations issued 

pursuant thereto, such certification may be 

made by Animal and Plant Health Inspection 

Service upon request of the licensee.
Labels 23 of 34

(f) Multiple-dose final containers of liquid 

biological product and carton tray covers 

showing required labeling information are 

subject to the requirements in this paragraphs.

(1) If a carton label or an enclosure is 

required to complete the labeling for a 

multiple-dose final container of liquid 

biological product, only one final container, 

with a container of diluent if applicable, shall 

be packaged in each carton: Provided, That 

if the multiple dose final container is fully 

labeled without a carton label or enclosure, 

two or more final containers, and a

corresponding number of diluent containers, 

may be packaged in a single carton which 

shall be considered a shipping box. Labels 

or stickers for shipping boxes shall not 

contain false or misleading information, but 

need not be submitted to APHIS for 

approval.

(2) When required labeling information is 

shown on a carton tray cover, it must be 

printed on the outside face of such tray 

cover where it may be read without opening 

the carton. The inside face of the tray cover 

may contain information suitable for an 

enclosure.

(f) If a carton label or an enclosure is required to 

complete the labeling for a multiple-dose final 

container of liquid biological product, only one 

final container shall be packaged in each 

carton: Provided, That if the multiple-dose final 

container is fully labeled without a carton label 

or enclosure, two or more final containers may 

be packaged in a single carton which shall be 

considered a shipping box. Labels or stickers 

for shipping boxes shall not contain false or 

misleading information but need not be 

submitted for approval.

§ 112.3 Diluent labels. Each final container of diluent, other than a liquid biological product, packaged with 

desiccated biological products shall bear a label that includes the following:

(a) The name—Sterile Diluent.

(b) True name of the biological product with which the diluent is packaged, except that when the firm 

packages all desiccated biological products with the same diluent, or two or more types of diluent are 

used, and the licensees' methods of identification and storage insure that all products are packaged 

with the correct type of diluent, labels affixed to the containers of diluent are exempt from this 

provision.

(c) The recoverable quantity of contents in cubic centimeters (cc) or milliliters (ml).

(d) A serial number by which the diluent can be identified with the manufacturer's records of 

preparation;

(e) Name and address of the licensee or the permittee;

(f) In the case of a diluent with which a desiccated biological product is to come in contact while the 

diluent is in its original container; and, 

(1) Is in a multiple-dose container, a positive warning that all of the biological product shall be 

used at the time the container is first opened; and/or

New Old

(2) The biological product is composed of viable 

or dangerous organisms or viruses, the notice,

‘‘Inactivate unused contents before disposal.’’

(2) The biological product is composed of viable 

or dangerous organisms or viruses, the notice, 

“Burn this container and all unused contents,” 

except that, in the case of a small one-dose 

container, the statement “Burn this container” or 

“Burn this vial” may be used.
Labels 24 of 34

(g) The establishment license number or the permit number, as the case may be, in one of the forms 

provided in § 112.2(a)(3).

§ 112.4 Subsidiaries, divisions, distributors, and permittees. Labels used by subsidiaries, divisions, 

distributors, and permittees shall be affixed by the licensee in a licensed establishment where the product 

is produced. Such labels shall comply with requirements for their review, approval, and filing as provided 

in the regulations.

(a) Subsidiaries. Labels to be used on a licensed biological product prepared by a subsidiary 

operating in a licensed establishment shall be submitted in accordance with § 112.5. Only labels 

approved for use on such product shall be used by the subsidiary.

(b) Divisions. Labels to be used on a licensed biological product prepared in a licensed establishment 

for distribution by a division or marketing unit of the licensee shall be submitted in accordance with 

§ 112.5. The name, address, and license number of the licensee shall be prominently placed on such 

labels. The relationship of the division or marketing unit to the licensee shall appear prominently on 

the label by use of the term “division of” or equivalent.

(c) Distributors. The name and address of the distributor or any statement, design, or device shall not 

be placed on the labels or containers of a licensed biological product in a manner which could be 

false or misleading or which could indicate that the distributor is the manufacturer of such product or 

operating under the license number shown on the label. The manufacturer shall be identified by 

name, address, and license number with the term “manufactured by,” “produced by,” or an equivalent 

term prominently placed in connection therewith. The name and address of the distributor may be 

placed on labels or containers if the term “distributor,” or “distributed by,” or an equivalent term is 

prominently placed in connection therewith.

(d) Permittees. The name and address of the permittee and any statement, design, or device shall not 

be placed on the labels or containers of a biological product imported for sale and distribution in 

accordance with § 104.5 in a manner which could be false or misleading or which could falsely 

indicate that the permittee is the manufacturer of such product. The manufacturer shall be identified 

by name and address with the term “manufactured by,” “produced by,” or an equivalent term 

prominently placed in connection therewith. Reference to the permittee shall be made by name, 

address, and permit number with the term “imported by,” “produced for,” or an equivalent term 

prominently placed in connection therewith. 

§ 112.5 Review and approval of labeling. Labels used with biological products prepared at licensed 

establishments or imported for general distribution and sale must be submitted to the Animal and Plant 

Health Inspection Service for review for compliance with the regulations and approval in writing prior to 

use, except as provided in paragraph (d) of this section and under the master label system provided in 

paragraph (e) of this section.

New Old

(a) Transmittal forms, available on the Internet at 

https://www.aphis.usda.gov/aphis/ourfocus/animal

health/veterinarybiologics/sa_bio_forms/ct_vb_forms, shall be 

used with each submission of sketches (including 

proofs) and labels. Separate forms shall be used 

for each biological product but only one copy of 

the form shall be used for all sketches and labels 

submitted at the same time for the same biological 

product.

(a) Transmittal forms, available on the Internet at 

(http://www.aphis.usda.gov/animallhealth/

vetlbiologics/vblforms.shtml), shall be used with 

each submission of sketches (including proofs) 

and labels. Separate forms shall be used for each 

biological product but only one copy of the form

shall be used for all sketches and labels submitted 

at the same time for the same biological product.

(b) A data summary, available on the Internet at 

productdata.aphis.usda.gov, shall be used with 

each submission of efficacy and safety data in 

support of a label claim. Manufacturers will submit 

the efficacy and safety data information with either 

the efficacy and safety studies or at the time of 

label submission. This information will be posted 

This subsection did not exist prior to 2016. When 

the new subsection b was added, old sections b 

through g were redesignated as c through h.
Labels 25 of 34 

New Old

at productdata.aphis.usda.gov to allow public 

disclosure of product performance.

No change other than redesignating the Sketch 

reg as (c). 

(b) Sketches may be submitted for comment to 

Animal and Plant Health Inspection Service by the 

licensee or permittee before preparing the finished 

label. Such sketches shall be returned to the 

licensee or permittee with comments, if any. 

Failure of the reviewer to take exception to a 

sketch shall not constitute approval of a finished 

label subsequently prepared.

(d) 

(1) Labels must be submitted to the Animal 

and Plant Health Inspection Service for review 

and written approval. Only labels which are 

approved as provided in paragraph (e) of this 

section may be used. When changes are 

made in approved labels, the new labels shall 

be subject to review and approval before use: 

Provided, That certain minor changes may be 

made in labels for products with approved 

labels or master labels, and the revised labels 

may be used prior to review by APHIS, with 

the provision that a new label or master label 

bearing these changes is submitted to APHIS 

for review and written approval within 60 days 

of label use, and that such minor changes do 

not render the product mislabeled or the label 

false and misleading in any particular.

(2) Minor label changes that may be made 

under the provision for products with 

approved labels or master labels are:

(i) Changes in the physical dimensions of 

the label provided that such change does 

not affect the legibility of the label;

(ii) Change in the color of label print or 

background, provided that such change 

does not affect the legibility of the label;

(iii) The addition or deletion of a Trade

Mark (TM) or Registered (R) symbol;

(iv) The correction of typographical errors;

(v) Adding, changing, or deleting label 

control numbers of bar codes; and

(vi) Revising or updating logos.

(vii) Changing the telephone contact

number;

(viii) Adding, changing, or deleting an

email and/or Web site address;

(ix) Changing the establishment

license or permit number assigned by

APHIS, and/or changing the name and/

or address of the manufacturer or

permittee, provided that such changes

are identical to information on the

current establishment license or permit;

(c) 

(1) Labels must be submitted to the Animal 

and Plant Health Inspection Service for review 

and written approval. Only labels which are 

approved as provided in 112.5(d) may be 

used. When changes are made in approved 

labels, the new labels shall be subject to 

review and approval before use: Provided,

That certain minor changes may be made in 

labels for products with approved labels or 

master labels, and the revised labels may be 

used prior to review by APHIS, with the 

provision that a new label or master label 

bearing these changes is submitted to APHIS 

for review and written approval within 60 days 

of label use, and that such minor changes do 

not render the product mislabeled or the label 

false and misleading in any particular.

(2) Minor label changes that may be made 

under the provision for products with 

approved labels or master labels are:

(i) Changes in the physical dimensions of 

the label provided that such change does 

not affect the legibility of the label;

(ii) Change in the color of label print, 

provided that such change does not affect 

the legibility of the label;

(iii) The addition or deletion of a Trade 

Mark (TM) or Registered (R) symbol;

(iv) The correction of typographical errors;

(v) Adding or changing label control 

numbers of bar codes; and

(vi) Revising or updating logos.
Labels 26 of 34

New Old

and

(x) Adding or changing the name and/

or address of a distributor.

(e) Labels and sketches submitted shall be 

prepared in the number and manner prescribed in 

this paragraph.

(1) Copies required:

(i) For label sketches, submit two copies 

of each sketch of a final container label, 

carton label, and enclosure. Sketches 

must be legible, and must include all 

information specified in § 112.2. One copy 

of each sketch will be returned with 

applicable comments, and one copy will 

be held on file by APHIS for no more than 

one year after processing, until replaced 

by a finished label: Provided, That 

sketches submitted in support of an 

application for a license or permit shall be

held as long as the application is 

considered active.

(ii) For master label sketches, submit for 

each product two copies of each sketch of 

an enclosure, label for the smallest size 

final container, and carton label; Provided,

That labels for larger size containers 

and/or cartons that are identical, except 

for physical dimensions, need not be 

submitted. One copy of each master label 

sketch will be returned with applicable 

comments, and one copy will be held on 

file by APHIS for one year after 

processing, until replaced by a finished 

master label that is submitted according 

to paragraph (e)(1)(iii) of this section: 

Provided, That master label sketches 

submitted in support of an application for 

license or permit shall be held as long as 

the application is considered active.

(iii) For finished labels, submit two

copies of each finished final container

label, carton label, and enclosure:

Provided, That when an enclosure is to

be used with more than one product,

one extra copy shall be submitted for

each additional product. One copy of

each finished label will be retained by

APHIS. One copy will be stamped and

returned to the licensee or permittee. 

Labels to which exceptions are taken 

shall be marked as sketches and handled 

under paragraph (e)(1)(i) of this section.

(iv) For finished master labels, submit

for each product two copies each of the

enclosure and the labels for the smallest

(d) Labels and sketches submitted shall be 

prepared in the number and manner prescribed in 

this paragraph.

(1) Copies required:

(i) For label sketches, submit two copies 

of each sketch of a final container label, 

carton label, and enclosure. Sketches 

must be legible, and must include all 

information specified in § 112.2. One copy 

of each sketch will be returned with 

applicable comments, and one copy will 

be held on file by APHIS for no more than 

one year after processing, until replaced 

by a finished label: Provided, That 

sketches submitted in support of an 

application for a license or permit shall be 

held as long as the application is 

considered active.

(ii) For master label sketches, submit for 

each product two copies of each sketch of 

an enclosure, label for the smallest size 

final container, and carton label; Provided,

That labels for larger size containers 

and/or cartons that are identical, except 

for physical dimensions, need not be 

submitted. One copy of each master label 

sketch will be returned with applicable 

comments, and one copy will be held on 

file by APHIS for one year after 

processing, until replaced by a finished 

master label that is submitted according 

to paragraph (e)(1)(iii) of this section: 

Provided, That master label sketches 

submitted in support of an application for 

license or permit shall be held as long as 

the application is considered active.

(iii) For finished labels, submit two copies 

of each finished final container label, 

carton label, and enclosure: Provided,

That when an enclosure is to be used with 

more than one product, one extra copy 

shall be submitted for each additional 

product. One copy of each finished label 

will be retained by APHIS. One copy will 

be stamped and returned to the licensee. 

Labels to which exceptions are taken 

shall be marked as sketches and handled 

under paragraph (d)(1)(i) of this section.

(iv) For finished master labels, submit for

each product two copies each of the 

enclosure and the labels for the smallest 

size final container and carton. Labels for 
Labels 27 of 34

New Old

size final container and carton. Labels

for larger sizes of containers or cartons

of the same product that are identical,

except for physical dimensions, need

not be submitted. Such labels become

eligible for use concurrent with the

approval of the appropriate finished

master label, provided that the

marketing of larger size final containers

is approved in the filed Outline of

Production, and the appropriate larger

sizes of containers or cartons are

identified on the label mounting sheet.

When a master label enclosure is to be

used with more than one product, one

extra copy for each additional product

shall be submitted. One copy of each

finished master label will be retained by

APHIS. One copy will be stamped and

returned to the licensee or permittee.

Master labels to which exception are

taken will be marked as sketches and

handled under paragraph (e)(1)(ii) of

this section.

(2) Mounting:

(i) Each label or sketch shall be securely 

fastened to a separate sheet of heavy 

bond paper (81/2′′ × 11′′) in such a 

manner that all information is available for 

review.

(ii) Two-or three-part cartons, including 

“sleeves,” shall be considered as one 

label. All parts shall be submitted 

together.

(iii)

(A) When two final containers are 

packaged together in a combination 

package, the labels for each shall be 

mounted on the same sheet of paper 

and shall be treated as one label. For 

diagnostic test kits, the labels for use 

on the individual reagent containers 

to be included in the kit shall be 

mounted together on a single sheet of 

paper, if possible; if necessary, a 

second sheet of paper may be used. 

The carton label and enclosure shall 

be mounted on separate individual 

sheets.

(B) If either final container label is 

also used alone or in another 

combination package, sets of 

separate labels for each biological 

product with which it is used shall be 

submitted for review.

larger sizes of containers or cartons of the 

same product that are identical, except for 

physical dimensions, need not be 

submitted. Such labels become eligible 

for use, concurrent with the approval of 

the appropriate finished master label: 

Provided, That the marketing of larger 

sizes of final containers is approved in the 

filed Outline of Production, and the 

appropriate larger sizes of containers or 

cartons are identified on the label 

mounting sheet. When a master label 

enclosure is to be used with more than 

one product, one extra copy for each 

additional product shall be submitted. One 

copy of each finished master label will be 

retained by APHIS. One copy will be 

stamped and returned to the licensee. 

Master labels to which exceptions are 

taken will be marked as sketches and 

handled under paragraph (e)(1)(ii) of this 

section.

(2) Mounting:

(i) Each label or sketch shall be securely 

fastened to a separate sheet of heavy 

bond paper (81/2′′ × 11′′) in such a 

manner that all information is available for 

review.

(ii) Two-or three-part cartons, including 

“sleeves,” shall be considered as one 

label. All parts shall be submitted 

together.

(iii)

(A) When two final containers are 

packaged together in a combination 

package, the labels for each shall be 

mounted on the same sheet of paper 

and shall be treated as one label. For 

diagnostic test kits, the labels for use 

on the individual reagent containers 

to be included in the kit shall be 

mounted together on a single sheet of 

paper, if possible; if necessary, a 

second sheet of paper may be used. 

The carton label and enclosure shall 

be mounted on separate individual 

sheets.

(B) If either final container label is 

also used alone or in another 

combination package, sets of 

separate labels for each biological 

product with which it is used shall be 

submitted for review.

(iv) When the same final container label is 

applied by different methods such as 
Labels 28 of 34

New Old

(iv) When the same final container label is 

applied by different methods such as 

paper or screen printing, one of each shall 

be mounted on the same sheet of paper 

as one submission.

(3) To appear on the top of each page:

(i)

(A) Name and product code number 

of the biological product as it appears 

on the product license or permit.

(B) Extra copies of enclosures to be 

used with another product shall bear 

the name and code number of the 

product affected.

(ii)

(A) Designation of the specimen as a 

label or master label: sketch, final 

container label, carton label, or 

enclosure.

(B) If two final container labels or 

multiple parts are on one sheet, each 

shall be named, and the label or part 

being revised shall be designated.

(iii) Size of package (dose, ml., cc., or 

units) for which the labels or enclosures 

are to be used.

(4) To appear on the bottom of each page in 

the lower left hand corner, if applicable:

(i) The dose size(s) to which the master 

label applies.

(ii) The APHIS assigned number for the 

label or sketch to be replaced. 

(iii) The APHIS assigned number for the 

label to be used as a reference for 

reviewing the submitted label.

paper or screen printing, one of each shall 

be mounted on the same sheet of paper 

as one submission.

(3) To appear on the top of each page:

(i)

(A) Name and product code number 

of the biological product as it appears 

on the product license or permit.

(B) Extra copies of enclosures to be 

used with another product shall bear 

the name and code number of the 

product affected.

(ii)

(A) Designation of the specimen as a 

label or master label: sketch, final 

container label, carton label, or 

enclosure.

(B) If two final container labels or 

multiple parts are on one sheet, each 

shall be named, and the label or part 

being revised shall be designated.

(iii) Size of package (dose, ml., cc., or 

units) for which the labels or enclosures 

are to be used.

(4) To appear on the bottom of each page: 

The reason for and information relevant to the 

submission shall be stated in the lower left 

hand corner as:

(i) Master label dose sizes approved for 

code ______.

(ii) Replacement for label, master label, 

and/or sketch No. ______.

(iii) Reference to label or master label No. 

______.

(iv) Addition to label No. ______.

(v) License Application Pending ______.

(vi) Foreign Language copy of Label No. 

______.

(f) Special requirements for foreign language 

labels:

(1) An accurate English translation must 

accompany each foreign language label 

submitted for approval. A statement affirming 

the accuracy of the translation must also be 

included.

(2) If the foreign language label is not a direct 

translation of an approved domestic label, an 

English version shall be submitted with an 

explanation for the difference in texts.

(3) Foreign language portion of a bilingual 

label shall be a true translation of the English 

portion. Reference to additional information 

on the enclosure shall not be made unless 

that enclosure is also bilingual.

(e) Special requirements for foreign language 

labels:

(1) If true, a statement that the label is a direct 

translation from a corresponding approved 

domestic label.

(2) If the foreign language label is not a direct 

translation of an approved domestic label, an 

English version shall be submitted with an 

explanation for the difference in texts.

(3) Foreign language portion of a bilingual 

label shall be a true translation of the English 

portion. Reference to additional information 

on the enclosure shall not be made unless 

that enclosure is also bilingual.
Labels 29 of 34

New Old

No change except redesignating as section g (f) When a request is received from Animal and 

Plant Health Inspection Service, the licensee or 

permittee shall submit a list of all approved labels 

currently being used. Each label listed shall be 

identified as to:

(1) Name and product code number as it 

appears on the product license or permit for 

the product; and

(2) Where applicable, the size of the package 

(doses, ml., cc., or units) on which the label 

shall be used; and

(3) Label number and date assigned; and 

(4) Name of licensee or subsidiary appearing 

on the label as the producer.(h) At the time of 

an inspection, or when requested by APHIS, 

licensees or permittees shall make all labels 

and master labels, including labels approved 

for use but exempted from filing under the 

master label system, available for review by 

authorized inspectors. Such labels shall be 

identical to the approved label or master label 

except for physical dimensions, reference to 

recoverable volume or doses and/or certain 

minor differences permitted in accordance 

with paragraph (d) of this section.

§ 112.6 Packaging biological products. 

New Old

(a) Multiple-dose final containers of a biological 

product with final container labeling including all 

information required under the regulations may be

packaged one or more per carton with a 

container(s) of the proper volume of diluent, if 

required, for that dose as specified in the filed 

Outline of Production: Provided, That cartons

containing more than one final container of 

product must comply with the conditions set forth 

in paragraphs (c)(1) through (4) of this section.

Multiple-dose final containers of a product that 

require a carton or enclosure in order to provide 

all information required under the regulations shall 

be packaged one container per carton with the 

proper volume of diluent, if required, for that dose 

as specified in the filed Outline of Production.

(a) Each multiple-dose final container of a 

biological product which requires a diluent for 

administration shall be packaged in an individual 

carton with a container of the proper volume of 

diluent for that dose as specified in the filed 

Outline of Production. Each multiple-dose final 

container of a product which does not require a 

diluent for administration need not be packaged in 

an individual carton unless the final container 

labeling does not contain all information required 

by the regulations. Such information must be 

included in or on a carton. Exceptions are 

provided in paragraphs (c) 

and (d) of this section and § 112.8.

(b) Single-dose final containers of a product need not be packaged one per carton. For single-dose 

products which require a diluent for administration, the number of containers of the proper amount of 

diluent specified in the filed Outline of Production for the number of doses contained in the carton 

shall be included in each carton.
Labels 30 of 34

(c) Poultry products for mass administration (including but not limited to administration through 

drinking water and spray) and products used in automatic vaccinating systems (including but not 

limited to pneumatic beak injectors and automated needle injectors) may be packaged in multipledose final containers as specified in the filed Outline of Production. Poultry products for manual 

administration to individual birds shall not exceed 1,000 doses in each final container. Diluent need 

not be packaged with the final container(s) of the product, but the licensee shall provide the required 

number of containers of diluent as specified in the filed Outline of Production. The following 

requirements apply to cartons containing more than one final container of poultry product:

(1) They shall be sealed prior to leaving the licensed establishment.

(2) The contents may not be repackaged.

(3) The contents of such cartons may not be sold in fractional units.

(4) The following statement must appear in a prominent place on the carton label: “Federal 

regulations prohibit the repackaging or sale of the contents of this carton in fractional units. Do 

not accept if seal is broken.”

(d) Diluent for the following products need not be packaged with the final container(s) of the product, 

but the licensee shall provide the consumer with the required number of containers of the proper

amount of diluent as specified in the filed Outline of Production:

(1) Marek's Disease Vaccine.

(2) Poultry vaccines administered to individual birds using automatic vaccinating equipment.

(e) Final containers of biological product prepared at a licensed establishment, or imported, in cartons 

or other containers shall not be removed from such cartons or containers for sale or distribution, 

unless each final container bears, or is packaged in a carton with, complete and approved labeling 

which is affixed to or included with each container by the licensed establishment producing the 

product or by the producer in the case of imported product: Provided, That this paragraph is not 

intended to apply to licensed veterinary practitioners administering or dispensing biological products 

in the course of their practice under a veterinary-client-patient-relationship as that term is used in 

§ 107.1.

(f) Labels which are affixed to or included with a biological product shall not be removed or altered in 

any manner.

§ 112.7 Special additional requirements. The label requirements in this section are additional to those 

prescribed elsewhere in this part.

(a) In the case of biological products containing live Newcastle Disease virus, a caution statement 

indicating that Newcastle Disease can cause inflammation of the eyelids of humans, and a warning to 

the user to avoid infecting his eyes shall be included on the enclosure.

(b) In the case of a biological product containing infectious bronchitis virus, all labels shall show the 

infectious bronchitis virus type or types used in the product. Abbreviation is permitted.

(c) In the case of a biological product containing inactivated rabies virus, carton labels, enclosures, 

and all but very small final container labels shall include a warning against freezing and the 

recommendations provided in this paragraph.

(1) That vaccine be administered to animals at 3 months of age or older, with a repeat dose 1 

year later.

(2) Subsequent revaccination as determined from the results of duration of immunity studies 

conducted as prescribed in § 113.209, paragraph (b) or (c), or both.

(d) In the case of a biological product containing modified live rabies virus, the carton labels, 

enclosures, and all but very small final container labels shall include the recommendations provided 

in this paragraph.

(1) For low egg-passage (below the 180th egg-passage level) the statement “For Use in Dogs 

Only! Not For Use in Any Other Animal!”

(2) For other vaccines containing modified live rabies virus, the statement “For Use In (designate 

animal(s)) Only! Not For Use In Any Other Animal!”

(3) Intramuscular injection at one site in the thigh shall be recommended.

(4) The statement “In event of accidental exposure to the vaccine virus, the possible hazard to 

human health should be considered and State Public Health Officials should be consulted for 

specific recommendations” shall be prominently placed on all carton labels and on enclosures, if 

used.
Labels 31 of 34

(5) That vaccine be administered to animals at 3 months of age or older, with a repeat dose 1 

year later.

(6) Subsequent revaccination as determined from the results of duration of immunity studies 

conducted as prescribed in § 113.312, paragraph (b) or (c), or both.

New Old

(e) Labeling for all products for use in mammals 

must bear an appropriate statement concerning 

use in pregnant animals.

(1) For bovine rhinotracheitis vaccine or 

bovine virus diarrhea vaccine containing 

modified live virus, all labeling except small 

final container labels shall bear the following 

statement: ‘‘Do not use in pregnant cows or 

in calves nursing pregnant cows.’’: 

Provided, That such vaccines which have 

been shown to be safe for use in pregnant 

cows may be excepted from this label 

requirement by the Administrator.

(2) For other modified live and inactivated 

vaccine, labeling shall bear a statement 

appropriate to the level of safety that has 

been demonstrated in pregnant animals.

(i) Products known to be unsafe in 

pregnant animals shall include 

statements such as ‘‘Do not use in 

pregnant animals,’’ or ‘‘Unsafe for use in 

pregnant animals,’’ or an equivalent 

statement acceptable to APHIS.

(ii) Products without safety 

documentation acceptable to APHIS, 

but not known to be unsafe, labeling 

shall include the statement ‘‘This 

product has not been tested in pregnant 

animals’’ or an equivalent statement 

acceptable to APHIS.

(3) For modified live vaccines containing 

agents with potential reproductive effects 

but having acceptable pregnant animal 

safety data on file with APHIS, labeling still 

must bear the following statement 

concerning residual risk: ‘‘Fetal health risks 

associated with the vaccination of pregnant 

animals with this vaccine cannot be 

unequivocally determined during clinical 

trials conducted for licensure. Appropriate 

strategies to address the risks associated 

(e) In the case of bovine rhinotracheitis vaccine 

containing modified live virus, all labeling except 

small final container labels shall bear the 

following statement: “Do not use in pregnant 

cows or in calves nursing pregnant cows.”: 

Provided, That such vaccines which have been 

shown to be safe for use in pregnant cows may 

be excepted from this label requirement by the 

Administrator.
Labels 32 of 34

with vaccine use in pregnant animals should 

be discussed with a veterinarian.’’

(f) For biological products recommending annual 

booster vaccinations, such recommendations 

must be supported by data acceptable to 

APHIS. In the absence of data that establish the 

need for booster vaccination, labeling must bear 

the following statement: ‘‘The need for annual 

booster vaccinations has not been established 

for this product; consultation with a veterinarian 

is recommended.’’

(f) Unless otherwise authorized in a filed Outline 

of Production, labels for inactivated bacterial 

products shall contain an unqualified 

recommendation for a repeat dose to 

accomplish primary immunization to be given at 

an appropriate time interval: Provided, That, 

repeat dose recommendations prescribed in 

paragraphs (f)(1) through (3) of this section are 

required for products containing the fractions 

listed.

(1) Clostridium haemolyticum. “Repeat the 

dose every 5 or 6 months in animals subject 

to reexposure.”

(2) Erysipelothrix rhusiopathiae. “Swine: For 

breeding animals, repeat after 21 days and 

annually. Turkeys: Repeat dose every 3 

months.”

(3) Clostridium botulinum Type C.

“Revaccinate breeders 1 month before 

breeding.”

(g) In the case of a liquid product authorized in a filed Outline of Production to be used as a diluent in 

a combination package, the carton labels and enclosures used for serials which are either not tested 

for bactericidal or viricidal activity or have been found unsatisfactory by such test shall contain the 

statement: “CAUTION: DO NOT USE AS DILUENT FOR LIVE VACCINES.”

(h) In the case of wart vaccine, recommendations shall be limited to use in cattle. Indications for use 

shall be for prophylactic use only, as an aid in the control of viral papillomas (warts). All labels shall 

include a dosage recommendation of at least 10 ml to be given subcutaneously and the dose 

repeated in 3 to 5 weeks.

New Old

(i) All but very small final container labels for 

feline panleukopenia vaccines shall contain the 

following recommendations for use:

(1) Killed virus vaccines. Vaccinate healthy 

cats with one dose, except that if the animal 

is less than 12 weeks of age, a second 

dose should be given no earlier than 16 

weeks of age.

(2) Modified live virus vaccines. Vaccinate 

healthy cats with one dose, except that if 

the animal is less than 12 weeks of age, a 

second dose should be given no earlier 

than16 weeks of age.

(i) Unless otherwise authorized in an Outline of 

Production filed subsequent to the effective date 

of these amendments, all but very small final 

container labels for Feline Panleukopenia 

Vaccines shall contain the following 

recommendations for use:

(1) Killed virus vaccines. Vaccinate healthy 

cats of any age with one dose except that if 

the animal is less than 12 weeks of age, a 

second dose should be given at 12 to 16 

weeks of age. Annual revaccination with a 

single dose is recommended.

(2) Modified live virus vaccines. Vaccinate 

healthy cats of any age with one dose

except that if the animal is less than 12 

weeks of age, a second dose should be 

given at 12 to 16 weeks of age. Annual 

revaccination with a single dose is 

recommended. Do not vaccinate pregnant 

cats.
Labels 33 of 34

(j) In the case of normal serum, antiserum, or antiserum derivatives, the type of preservative used 

shall be indicated on all labels.

(k) Unless acceptable data has been filed with Animal and Plant Health Inspection Service, to show 

that development of corneal opacity is not associated with the product, carton labels and enclosures 

used with biological products containing modified live canine hepatitis virus or modified live canine 

adenovirus Type 2 shall bear the following statement: “Occasionally, transient corneal opacity may 

occur following the administration of this product.”

New Old

(l) All labels for autogenous biologics must 

specify the name of the microorganism(s) or 

antigen(s) that they contain, and shall bear the 

following statement: ‘‘Potency and efficacy of

autogenous biologics have not been 

established. This product is prepared for use 

only by or under the direction of a veterinarian 

or approved specialist.’’

(l) All labels for autogenous biologics shall bear 

the following statement: “Potency and efficacy 

of autogenous biologics have not been 

established. This product is prepared for use 

only by or under the direction of a veterinarian 

or approved specialist.”

(m) In the case of biological products containing Marek's disease virus, all labels shall specify the 

Marek's disease virus serotype(s) used in the product.

New Old

(n) All labels for conditionally licensed products 

shall bear the following statement: ‘‘This product

license is conditional; efficacy and potency have 

not been fully demonstrated.’’

Did not exist previously

§ 112.8 For export only. The applicable regulations for packaging and labeling a biological product 

produced in the United States shall apply to such biological product if exported from the United States 

except as otherwise provided in this section. Only labels approved as provided in § 112.5 shall be used.

(a) Biological products which have been packaged and labeled for export or which have been 

exported, shall be subject to the applicable provisions in this paragraph.

(1) After leaving the licensed establishment, a biological product shall not be bottled, repackaged, 

relabeled, or otherwise altered in any way while in the United States; and

(2) An exported biological product shall not be returned to the United States: Provided, That, in 

the case of a biological product exported in labeled final containers, the Administrator may 

authorize by permit the importation of a limited number for research and evaluation by the 

producing licensee; and

(3) An exported biological product which is bottled, rebottled, or altered in any way in a foreign 

country shall not bear a label which indicates by establishment license number that it has been 

prepared in the United States.

(b) Desiccated and frozen liquid products, packaged and labeled as for domestic use, may be 

exported without the diluent required for rehydration or dilution, as the case may be, if the labeling 

includes adequate instructions for preparing the product for use and the words “For Export Only”.

(c) Final containers of products, labeled or unlabeled, may be exported in sealed shipping boxes, 

adequately identified as to contents with an approved label, and plainly marked “For Export Only”: 

Provided, That such products shall not be diverted to domestic use.

(d) Completed inactivated liquid products, antiserums, and antitoxins, may be exported in large 

multiple-dose containers identified with an approved label that contains the words “For Export Only” 

prominently displayed.

(e) Concentrated inactivated liquid product, completed except for dilution to the proper strength for 

use, may be exported in large multiple-dose containers identified with an approved label that contains 

the words “For Export Only” prominently displayed. 
Labels 34 of 34

§ 112.9 Biological products imported for research and evaluation. A biological product imported for 

research and evaluation under a permit issued in accordance with § 104.4, with the exception of products 

imported under § 104.4(d), shall be labeled as provided in this section.

(a) The label shall identify the product and the name and address of the manufacturer and shall 

provide instructions for proper use of the product, including all warnings and cautions needed by the 

permittee to safely use the product.

(b) Labels on each product to be further distributed in accordance with § 103.3 shall bear the 

statement “Notice! For Experimental Use Only—Not for Sale!”

(c) The labeling shall contain any other information deemed necessary by the Administrator and 

specified on the permit. 

§ 112.10 Special packaging and labeling. A biological product, which requires special packaging and/or 

labeling not provided for in this part, shall be packaged and/or labeled in accordance with requirements 

written into the approved outline for such product.